A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lanabecestat; Drug: Dabigatran etexilate

• Registration Number: NCT02568397
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Study Start: 2015-10-31
• Primary Completion: 2016-01-31
• Study Completion: 2016-01-31
• Results First Submitted: 2018-12-13
• Results First Submitted QC: 2019-04-03
• Results First Posted: 2019-04-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Overtly healthy males and females

Exclusion Criteria

• Eye abnormalities or disease
• History of vitiligo or any skin color disorder
• Have a history psychiatric or brain disease including seizures
• Have smoked within the last 3 months
• Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
• Have known allergies to dabigatran etexilate and related compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lanabecestat and Dabigatran Etexilate	Dabigatran etexilate	Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.
Lanabecestat and Dabigatran Etexilate	Lanabecestat	Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.
Dabigatran Etexilate	Dabigatran etexilate	Single dose of dabigatran etexilate administered orally.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat	Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time	Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time	Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose	Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States